Janus

The Pilot: June 2005 - January 2006
NCI, FDA, CTIS, and IBM worked to build a clinical trial review application. This pilot application was built using the FDA-endorsed JANUS data model and caCORE application development technology. The goal of this effort was to prove that this approach could, in fact, help achieve a set of the CRIX project objectives, including:

• More efficient submissions based on standards
• Reproducible, custom datasets for analysis
• Reusable tools for analysis and review
• Less data redundancy
• Less time on orientation to data by reviewers
• Less ambiguity in communications of information
• More auditable data
• Less manual, paper processing
• Use of common standards across the entire community (government, industry, academia)
• Interoperability with other caBIG data sets, tools, capabilities

The JANUS warehouse was populated with sample synthesized human trial data related to two oncology studies. This data was furnished in standard STDM format and data load scripts were developed to import the data. A sample caCORE application was developed to demonstrate the analytical capabilities of such an application accessing the underlying JANUS repository. The application was modeled against SDTM domain views of the Janus warehouse instead of the warehouse schema itself to alleviate complexity and improve data access efficiency. The sample application was successful in that you could authenticate the users at signon using CSM authentication and then review the clinical trial data in the following ways:

• View patient enrollment by study
• View patient retention by study
• Efficacy reporting by study
• Safety reporting by study
• Historical norms
• Trend outcomes with prognostic factors
• Report generation

The Pilot had participation from various members of the CRIX ecosystem, including, FDA, NCI (CTEP, DCP, CIP), investigators, research nurses, data managers, and operational support staff (from Cancer Centers, Cooperative groups, Oncology Nursing Society) and pharma representation for industry sponsor needs.

Operational Prototype April 2006-September 2006

NCI, FDA, CTIS, and IBM are building an operational prototype of clinical trial review application based on the Janus data model. The operational prototype will load validated clinical and non-clinical submission datasets in SDTM and SEND formats into JANUS.

The operatonal prototype will validate the repository for use by FDA reveiewer by creating a tools integration framework to allow access to the JANUS data warehouse by commonly used tools like WebSDM, I-Review, SAS, S+ and Toxvision.

Part of this effort will also be to create roadmap and vision for JANUS at the FDA and NCI over the next 24 months and will address it in relation to CDUS, CTMS, caBIG, ODM, SDTM, and SEND.

Sample demonstration of Janus access using IBM Data Discovery and Query Builder
Sample demonstration of Janus access using an application developed with caCORE technology.